Pfizer's termination of its codevelopment agreement with Organon for the antipsychotic asenapine is indicative of the increasingly important role payer considerations play in development decisions, Pfizer CEO Jeffrey Kindler said.

Pfizer withdrew from the codevelopment deal Nov. 28 following a "commercial analysis of the compound as part of its overall portfolio." Asenapine failed to show a significant advantage over placebo in two of four clinical schizophrenia trials.

During a media briefing following a Nov. 30 investor meeting in Groton, Conn., Kindler said that while Pfizer believed the compound would ultimately receive FDA approval, the firm felt further investment was not warranted given asenapine's profile relative to other products.

With asenapine, "we exercised the discipline of saying, 'Okay, based on the data that we saw, although we believe this is a good drug and we believe it ultimately will be a safe and effective compound, the commercial potential it provides to us in an arrangement in which we are sharing with another company wasn't sufficient to justify further investment,'" he explained.

Pfizer Global Research & Development President John LaMattina said comparative effectiveness information has become the most important factor in determining whether to continue development of a compound.

"For many years, the major focus of Phase II was, A, is it safe in the patient population and, B, does it work and, to a certain extent, is it as effective or more effective" than existing therapies, LaMattina explained.

"I would say that third reason...now is becoming almost dominant," he said. "It is almost a given that it has to be safe and effective, but boy, it better offer at that stage a difference from existing therapies."

"It doesn't matter if you have got a whole new mechanism to treat whatever disease, if it is only as good as compounds that are already out there, by the time you invest and you've got that to market, you are now going against generics," he added.

The payers "are saying, 'Well this is generic. It's got loads of experience. Even though this is new, who cares.'"

Vice Chairman David Shedlarz said that demonstrating superior therapeutic value, in the absence of cost-effectiveness data, is increasingly "not adequate" for ensuring favorable coverage.

Customers are telling Pfizer, "'You have got to be doing the studying up front so when you come to us with this new product and give us a proven proposition that this not only has therapeutic value, but this has economic value at the same time," he added.

"Increasingly, you are developing things keeping in mind that the therapeutics have to be right and the economics have to be right as well," Shedlarz said.

Manufacturers have been incorporating payer considerations into premarket development programs more often in recent years. For example, Amgen is running head-to-head studies of many of its investigational compounds against market leading products (¹ Also see "Amgen Head-To-Head R&D Strategy Speaks To Growing Importance Of Payers" - Pink Sheet, 6 February, 2006., p. 21).

Since taking the helm at Pfizer, Kindler has emphasized the importance of demonstrating value to payers - a priority he reiterated during the Nov. 30 meeting (² Also see "McKindler? New Pfizer CEO Echoes McKinnell’s Views On Payers, Scale" - Pink Sheet, 25 September, 2006., p. 5).

"We are very focused on the fact that in the environment in which we are operating, payers have expectations for seeing evidence of value as well as of safe and effective drugs. We are very focused on finding ways to build that into development programs and to provide support for the proof of value when we go to market," he said.

Kindler cited Pfizer's therapeutic area teams, which manage development of compounds within therapeutic areas from Phase I through lifecycle management, as one vehicle for bringing reimbursement considerations into the development process.

The therapeutic area teams are "identifying those areas of unmet medical need where there is an opportunity to provide a unique and differentiated value," he said, noting that sometimes "that means foregoing certain opportunities."

Kindler added that ongoing monitoring of compounds' comparative effectiveness profiles is critical in making development decisions. "You can make the investment based on the clinical profile that you are expecting, but you have to continue to monitor it as it goes through."

- Andrew Kasper

Payers Having More Impact On R&D, Pfizer Says; Asenapine Is Early Casualty

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